Will advancing forms of artificial intelligence (AI) help to better integrate supply-chain data to make outsourcing development and manufacturing more efficient, productive and profitable? Only if it’s a human making the decisions.
With less than a year to go until the March 31, 2019 divorce date for the U.K. and the EU, one would be forgiven for thinking there would already be a plan in place to deal with an event that will have such a profound global impact on the pharmaceutical industry. However, manufacturers still seemingly have to prepare for any possibly scenario, while continuing to wait for clarity.
Knowing how to classify your device as either SR or NSR is not a clearly defined task. There are implications for each decision made as you proceed through development, and the burden is on you to understand and to provide what the FDA will require.
The process of establishing a defendable environmental monitoring (EM) sampling plan during performance qualification can be broken into six phases to increase the likelihood of success during inspection for licensure of a facility. This article discusses the final two phases.
Dedicated Fermentation Technology Replacing Stainless Steel Systems in Bioprocess Markets
Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.
A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.
This white paper gives an overview of modern tools and solutions, adding flexibility and speed to both upstream and downstream operations in flavivirus vaccine production.
A selection of fluid management components from GE Healthcare’s ReadyToProcess platform of disposable and single-use equipment was used to arrange buffer and sample management solutions for four typical large-scale chromatography setups.
Thermo Scientific™ Nunc™ Cell Factory™ systems are solutions designed for adherent cell culture. These systems consist of multiple polystyrene growth surfaces, assembled together to maximize the surface area available for cell growth while minimizing the incubator volume required for maintaining cells. Nunc Cell Factory systems are popular in fields where large quantities of cells are required and are a reliable tool for the production of vaccines, recombinant proteins, and for the generation of cell mass.
Current techniques used to separate adherent mammalian cells from microcarrier beads often use sophisticated equipment, requiring significant capital expenditure as well as routine maintenance, and cleaning and sterilization between uses.
This application note describes the physical characteristics of the XDR-2000 bioreactor system suitable for use in mammalian cell culture applications.
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OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
As novel medicines become a larger part of the industry's portfolio, it is critical you secure a supply chain and manufacturing processes that produce drugs in a reliable, cost-effective way.
Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays.
If, in the course of the development process, undesirable effects occur that negatively impact API scale-up, it can prevent a company from delivering a product with reliable quality and efficacy.
Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies, though much of their work happens behind the scenes.
At the early stages of product development, pharmaceutical development scientists are under increasing time pressure to select the right molecule form, the right formulation and the right final dose form.